A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novo Nordisk A/S
Study ID
NCT05718570
Status
Enrolling By Invitation

Conditions

  • Adult Growth Hormone Deficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Somapacitan — DRUG
    Sogroya therapy in participants with AGHD.

Study Details

In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.

Key Dates

Start date
Feb 3, 2023
Status verified
Apr 2026
Primary completion
Dec 15, 2032
Completion
Dec 15, 2032

Study Design

Enrollment
400 participants (estimated)

Arms

  • Arm: Participants with Adult Growth Hormone Deficiency (AGHD)
    Participants will be treated with commercially available Sogroya according to routine clinical practice at the discretion of the treating physician. The decision to treat a participant with Sogroya has been made prior to and independently from the decision to include the participant in this study.

Primary Outcome Measure

Number of Adverse drug reaction (ADRs) [ Time Frame: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) ]

Locations (29)

FacilityCityStateZIPSite coordinators
Barrow Neurological InstitutePhoenixArizona85013-
Keck Medical Center of USC - Outpatient ClinicLos AngelesCalifornia90033-
UCLA HealthLos AngelesCalifornia90095-
Stanford Univ School of MedPalo AltoCalifornia94304-
Advanced Rx Clinical ResearchWestminsterCalifornia92683-
Anschutz Outpatient PavilionAuroraColorado80045-
Metabolic Research Institute IncWest Palm BeachFlorida33401-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
Northwestern Medical GroupChicagoIllinois60642-
Johns Hopkins UniversityBaltimoreMaryland21287-
Brigham & Women's HospitalBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
Washington UniversitySt LouisMissouri63110-
UNMCOmahaNebraska68198-
Palm Research Center Inc-VegasLas VegasNevada89148-
Northern Nevada EndocrinologyRenoNevada89511-
Cornell UniversityNew YorkNew York10021-
NYU Langone Orthopedic CenterNew YorkNew York10017-
University of North CarolinaChapel HillNorth Carolina27514-
Physicians East EndocrinologyGreenvilleNorth Carolina27834-
Oregon Health & Science UniversityPortlandOregon97239-
St Lukes Physician GroupCenter ValleyPennsylvania18034-
Revival Research Institute, LLCDallasTexas75231-
UT Southwestern Medical Center-CRUDallasTexas75390-
EP Premier Medical Group PAEl PasoTexas79935-
Consano Clinical Research, LLCShavano ParkTexas78231-
Puget Sound VA, University of WashingtonSeattleWashington98108-1597-
University Of Washington_SeattleSeattleWashington98195-6165-

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